Airway Morbidity
Conditions
Brief summary
The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.
Interventions
PROCEDUREfunction tests
ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
DEVICELMA SupremeTM
DEVICEAmbu-Aura GainTM
Sponsors
Krankenhaus Bozen
Schulthess Klinik
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA 1 or 2 * Age 19-65 yr * Written informed consent
Exclusion criteria
* Difficult airway * Non fasted * BMI \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oropharyngeal seal pressure | 5 minutes | Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anatomic position | 5 minutes | The anatomic position was assessed by passing a fiberoptic scope through the airway tube stopping 0,5 cm prior to the end of the tube. The airway tube view was scored using an established scoring system. |
Countries
Italy, Switzerland
Contacts
Primary ContactChristian Keller, MD MSc
Outcome results
None listed